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+91 9266125395
Mon - Sat: 9:00 - 18:00 IST
Surgeine Healthcare provides direct technical support, regulatory compliance dossiers, and international shipping options for healthcare providers and medical distributors worldwide.
+91 9266125395
Mon - Sat: 9:00 - 18:00 IST+91 9266125395
Instant messaging for overseas procurementA-310, Urban Square, Sector-62, Golf Course Ext. Rd, Gurugram, Haryana-122101, INDIA
Operating four cleanroom manufacturing plants, Surgeine Healthcare partners with Group Purchasing Organisations (GPOs), regional distributors, and brand owners across 25+ countries.
We supply complete regulatory registration support, including EU MDR 2017/745 Technical Files, ISO 13485:2016 certificates, declarations of conformity, sterilization validation, and biocompatibility test reports.
Configure custom component lists, drape dimensions, gown barrier protection (AAMI PB70 Levels 2-4), and folding sequences tailored to specific surgical protocols and tender guidelines.
Full support for OEM branding, private-label box artwork, multi-language instructions for use (IFU), unique device identification (UDI), and localized market compliance.
Surgeine Healthcare operates ISO 13485:2016 certified cleanrooms (Class 100K & 10K). Our products maintain CE marking under EU MDR 2017/745, and conform to AAMI PB70 barrier protection classifications and EN 13795 European surgical drape and gown performance standards.
We provide sample kits for clinical evaluation and hospital trial testing. Click the inquiry button below to detail your desired product specifications, required quantities, and target shipping destination.
Standard orders ship within 3 to 4 weeks upon order confirmation and artwork approval. Expedited dispatch schedules are available for tender fulfillment and high-priority medical supply commitments.
Connect directly with our export team to request technical dossiers, custom product quotations, or sample evaluation kits.